Hardware Podcasts

221 - What Is ICH and Why It Matters

Let's Combinate · 7 Jan 2026 · 14m

What this episode covers

Subhi Saadeh, host of Let's Combinate and founder of Let's Combinate BioWorks, explains the International Council for Harmonisation (ICH) and its critical role in drug-device combination products. He details the history of ICH, from its 1990 founding to its 2015 legal entity status, and outlines the five-step guideline development process involving regulators like the FDA, EMA, and PMDA. Saadeh emphasizes how ICH guidelines, particularly the Quality (Q) series such as Q8, Q9, Q10, Q12, and Q13, shape global expectations for lifecycle management, stability, and risk in products like auto-injectors and refilled syringes.

Most relevant to

established companies

Topics

Mentioned

Also
Let's Combinate BioWorks, ICH, FDA, EMA, PMDA, Health Canada, Swiss Medic, WHO, Combination Products Coalition, ASTM Committee E55, AAMI, Q1, Q2, Q3, Q4, Q6, Q7, Q8, Q9, Q10, Q11, Q12, Q13, Q14

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